We are seeking a meticulous and motivated QA Analyst to join our team. The QA Analyst will be responsible for ensuring the quality and reliability of our systems and processes through comprehensive audits, testing, and compliance with regulatory standards. The ideal candidate will have a strong attention to detail, excellent communication skills, and the ability to work collaboratively in a dynamic environment.
Key Duties and Responsibilities:
Perform Quality Assurance Audits: Conduct system process audits to identify inconsistencies and areas for improvement.
Quality Standards Development: Develop, review, and update quality standards to align with industry best practices.
Testing Processes: Create, update, and evaluate test cases; contribute to both manual and automated testing efforts to ensure optimal system performance.
Documentation: Develop, update, and maintain software documentation, standard operating procedures (SOPs), validation documentation, and other technical materials.
Regulatory Compliance: Ensure adherence to relevant regulatory requirements, including but not limited to CSV, 21 CFR Part 11, EU regulations, GxP, and GMP standards.
Skills and Qualifications:
Quick learner with the ability to adapt to new tools and processes.
Strong verbal communication and coaching skills.
Excellent written communication skills for clear and concise documentation.
Proven ability to work effectively in a team environment.
Goal-oriented with a focus on achieving the mission and vision of the organization.
Exceptional time management skills to prioritize tasks and meet deadlines.
Flexible working approach, capable of adapting to changing project requirements and timelines.
Preferred Experience:
Experience with manual and automated testing tools.
Familiarity with quality assurance frameworks and methodologies.
Knowledge of regulatory compliance standards in relevant industries.
